This just goes to show the bias that exists against Cytodyn.
The FDA initially said they wanted the 700mg dose and the only thing they needed was more safety data from that dosage. That was done by January. At that point they asked for all data from the monotherapy trial. That data would have little to no relevance to the combination trial because it would simply muddy the waters of what leronlimab does in combination with other drugs. Then they ask for data from the completed monotherapy trial.
Once the safety data was submitted there were no omissions or inadequacies. Adding data from a second trial would introduce significant impediments for the FDA to make a determination.
There have been no call outs by the FDA in regard to manufacturing and the information about the injectable kit was included in the BLA.
In other words F the corrupt FDA.
Quote:2. Is not necessarily a final decision regarding the scientific/medical merits of the application; instead, it is an early signal to the applicant that the application has omissions or inadequacies so severe as to render the application incomplete on its face or to introduce significant impediments to a prompt and meaningful review (e.g., the need for substantial amounts of additional data and analyses). This message is transmitted early so that "repairs" can be promptly initiated by the applicant.
The FDA initially said they wanted the 700mg dose and the only thing they needed was more safety data from that dosage. That was done by January. At that point they asked for all data from the monotherapy trial. That data would have little to no relevance to the combination trial because it would simply muddy the waters of what leronlimab does in combination with other drugs. Then they ask for data from the completed monotherapy trial.
Once the safety data was submitted there were no omissions or inadequacies. Adding data from a second trial would introduce significant impediments for the FDA to make a determination.
Quote:May apply if the application contains other uncorrected deficiencies (e.g., manufacturing or product specifications) which were clearly communicated to the applicant before submission of the application sufficient to require resolution before a meaningful review could occur.
There have been no call outs by the FDA in regard to manufacturing and the information about the injectable kit was included in the BLA.
In other words F the corrupt FDA.
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